Clascoterone is under clinical development by Cosmo Pharmaceuticals and currently in Phase III for Androgenic Alopecia. According to GlobalData, Phase III drugs for Androgenic Alopecia does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Clascoterone LoA Report. Buy the report here.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - Clascoterone in Androgenic Alopecia

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Clascoterone overview

Clascoterone (Winlevi) is a cortexolone 17alpha-propionate derivative acts as anti-acne agent. It is formulated as cream for topical application. Winlevi is indicated for treatment of acne vulgaris in patients with 12 years of age and older.
Clascoterone (CB-0301, Winlevi) is under development for the treatment of acne vulgaris, solid tumors including androgen-independent prostate adenocarcinoma, relapsed/refractory pancreatic adenocarcinoma, androgenetic alopecia, pilonidal sinus disease and relapsed/refractory triple negative breast cancer (TNBC). The drug candidate is a new chemical entity. It is administered through cutaneous (topical) route. The drug candidate is derived from 11-deoxycortisone that acts by targeting androgen receptor. It is developed based on Matrix MMX technology. It was also under development for the treatment of hirsutism.

Cosmo Pharmaceuticals overview

Cosmo Pharmaceuticals (Cosmo) develops drugs for the treatment of gastrointestinal diseases and dermatology. It develops pharmaceutical products based on its multi-matrix technology. The company’s pipeline products include breezula for androgenetic alopecia; CB-01-35 targets ulcerative colitis and proctitis; CB-01-33 treats bile acid diarrhea; and CB-03-10 targets pancreatic and colon cancers. It also offers eleview which is a submucosal injectable composition for use in gastrointestinal endoscopic procedures. The company’s manufacturing facility is located in Lainate, Milan. Cosmo is headquartered in Dublin, Ireland

For a complete picture of Clascoterone’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.